A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Mild to Moderate Infections of the Skin and the Supportive Layers Beneath the Skin
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with ciprofloxacin, another antibiotic, in the treatment of adults with mild to moderate infections of the skin and the supportive layers beneath the skin.
| Condition | Intervention | Phase |
|---|---|---|
|
Skin Diseases, Infectious Cellulitis |
Drug: levofloxacin |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Active-Controlled, Randomized Study to Evaluate the Safety and Efficacy of Levofloxacin Versus Ciprofloxacin HCl in the Treatment of Mild to Moderate Skin and Skin Structure Infections in Adults |
- Clinical response rate (defined as cured, improved or failed) 2 - 7 days after the last dose of the study drug; rate of elimination of disease-causing bacteria (by patient, and by type of bacteria); incidence of adverse events.
- Change in physical examination and in laboratory tests after treatment with the study drug.
| Enrollment: | 431 |
| Study Start Date: | July 1991 |
| Study Completion Date: | February 1993 |
Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (500 mg by mouth once daily for 7-10 days) compared with another frequently used antibiotic, ciprofloxacin (500 mg by mouth every 12 hours for 7 -10 days), in adults with mild to moderate infections of the skin and the supportive layers beneath the skin. The study consists of 3 visits: one visit [pre-therapy] for screening and enrollment, and two visits to assess safety and effectiveness (one visit [on-therapy] on Days 3 - 5 of the study and one visit [post-therapy] 2 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. The primary assessments of effectiveness include the clinical response to treatment (defined at post-therapy as cured, improved or failed) and the microbiological response at post-therapy (the rate of eradication of the disease-causing bacteria, determined by patient and by type of bacteria). Safety evaluations (incidence of adverse events, physical examination, physical examination of the skin, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with ciprofloxacin in patients with mild to moderate infections of the skin and the supportive layers beneath the skin. Levofloxacin 500 mg by mouth once daily, or ciprofloxacin 500 mg by mouth every 12 hours. The duration of treatment is 7 to 10 days.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of mild to moderate infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, drainage, swelling, or other relevant clinical signs
- tissue sample available from the area of the skin affected by the bacteria
- able to take medication by mouth
Exclusion Criteria:
- Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin
- having a severe infection
- previous allergic or serious adverse reactions to similar antibiotics
- taken antibiotics internally within 48 hours of the start of the study with resulting improvement
- require a second antibiotic taken internally or need an antibiotic applied directly to the site of the infection in addition to the study drug
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00257036 History of Changes |
| Other Study ID Numbers: | CR005476 |
| Study First Received: | November 18, 2005 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
Infectious skin diseases skin diseases bacterial skin diseases |
cellulitis quinolones levofloxacin |
Additional relevant MeSH terms:
|
Communicable Diseases Infection Skin Diseases Skin Diseases, Infectious Connective Tissue Diseases Cellulitis Suppuration Inflammation Pathologic Processes Ciprofloxacin |
Ofloxacin Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Anti-Bacterial Agents Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on June 18, 2013